Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112281
Status:
TERMINATED
Last Update Posted:
2006-08-04
First Post:
2005-06-01
Brief Title:
A Study of the Safety and Efficacy of Nitric Oxide Reduction in Patients With Cardiogenic Shock After a Heart Attack
Sponsor:
Arginox Pharmaceuticals
Organization:
Arginox Pharmaceuticals
Study Overview
Official Title:
A Phase III International Multi-Center Prospective Randomized Double-Blind Placebo-Controlled Study to Assess the Safety and Efficacy of Nitric Oxide Synthase Inhibition With Tilarginine Acetate Injection in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction or the TRIUMPH Trial
Status:
TERMINATED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from making a bodily substance called nitric oxide The body may produce excess nitric oxide following severe heart damage leading to shock During a heart attack and especially after a blocked artery causing the heart attack is reopened a large amount of nitric oxide is released into the heart muscle and into the blood Normally small amounts of nitric oxide are good for the heart and blood vessels However when released in large amounts such as during a heart attack it may be harmful by adding to the damage of the heart attack and lowering the hearts ability to pump blood to the body It may cause blood pressure to be lowered and reduce the amount of blood flow to the bodys vital organs This may interfere with the bodys organs being able to do their work If Tilarginine Acetate Injection can stop extra nitric oxide from being made the performance of the heart and blood flow to the organs may get better which may result in the improvement of symptoms The purpose of this study TRIUMPH is to investigate the safety and effectiveness of Tilarginine Acetate Injection compared to placebo an inactive fluid that has no effect on the body but looks exactly like the medication being studied The study will help determine whether Tilarginine Acetate Injection by temporarily lowering the amount of nitric oxide released into the vital organs can improve blood pressure and the blood flow to the bodys organs
Detailed Description:
An estimated 120000 to 160000 patients annually are diagnosed with cardiogenic shock CS in North America and Europe CS complicates approximately 5-14 of all cases of acute myocardial infarction AMI and is the most common cause of death in patients hospitalized with AMI Cardiogenic shock developing during the course of AMI is the end result of a pathophysiological cycle secondary to a sudden and significant decrease in cardiac contractility due to infarction ischemia and stunning of large myocardial segments It is not anticipated that further advances in reperfusion or revascularization therapy will have a significant additional impact on survival in patients with CS Modalities that protect the myocardium during ischemia and reperfusion are likely to be the next major advance in improving outcome in the setting of acute myocardial infarction MI especially in patients with large infarcts complicated by shock Preliminary studies investigating nitric oxide synthase NOS inhibition suggest that improvements in cardiovascular function and survival are possible by limiting formation of toxic NO The primary objective of the TRIUMPH study is to establish the efficacy of Tilarginine Acetate Injection compared to placebo in reducing all cause mortality at 30 days post randomization in patients with cardiogenic shock complicating acute myocardial infarction MI Safety objectives of this study include an evaluation of adverse events and serious adverse events and key laboratory parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None